The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
This is a Phase 1a/1b multicenter, open-label study in participants with advanced or metastatic solid tumor malignancies known to express Nectin 4. This study evaluates an antibody-drug conjugate that binds to the protein nectin-4, which is expressed on certain cancer cells, delivering the drug to the cancer. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4052031 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4052031 at the RP2D/optimal dose in expansion cohorts based on tumor type and/or treatment history.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Intravenous
City of Hope National Medical Center
Duarte, California, United States
RECRUITINGSarah Cannon Research Institute at HealthOne
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialists and Research Institute
St. Petersburg, Florida, United States
RECRUITINGUniversity of Chicago Hospital
Chicago, Illinois, United States
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Cycle 1 (21 Days)
Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: Up to Approximately 48 Months or 4 Years
To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
PK: Cmin of LY4052031
Time frame: Cycle 1 (21 Days)
To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)
PK: AUC of LY4052031
Time frame: Cycle 1 (21 Days)
To evaluate the preliminary antitumor activity of LY4052031: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1))
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031: Duration of response (DOR)
DOR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031: Time to response (TTR)
TTR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031: Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031: Disease control rate (DCR)
DCR per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4052031: Overall survival (OS)
OS per investigator assessed RECIST 1.1
Time frame: Up to Approximately 48 Months or 4 Years
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGSTART Midwest Cancer and Hematology Centers of W Michigan
Grand Rapids, Michigan, United States
RECRUITINGWashington University School of Medicine in St. Louis
St Louis, Missouri, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGColumbia University Irving Medical Center
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 18 more locations